A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Overall Response Rate
研究概览
简要总结
The purpose of this research study is to determine if lattice radiation therapy (LRT) will provide better treatment for bulky (large) tumors than current standard of care radiotherapy.
详细描述
This will be a single-institution, single-arm Phase II trial with an anticipated total of 37 patients enrolled. Treatment will consist of 5 fractions of lattice radiation therapy delivered every other day. The primary endpoints will include the efficacy of lattice therapy as evaluated by ORR (CR or PR per RECIST criteria) at 60 days (2 months) post-treatment and safety. Toxicity will be evaluated at day 5 (+/- 2 days), day 15 (+/- 5 days), day 30 (+/- 5 days), and day 60 (+/- 7 days) post-completion of lattice therapy. This study will also include a translational analysis of the impact of lattice therapy on systemic immune responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Solid tumor malignancy with a clinical indication for radiation
- •Patients must have measurable disease
- •Target lesion(s) which are amenable to lattice therapy plan
- •When applicable, target lesion for radiation amenable to immobilization during delivery of radiotherapy
- •Age ≥18 years.
- •ECOG Performance status ≤2
- •Life expectancy greater than 3 months
- •Women of child-bearing potential and men must agree to avoid conception via abstinence (ideal) or a method of birth control (e.g., hormonal or barrier method of birth control) prior to study entry and for at least 30 days after completion of lattice therapy administration.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients receiving cytotoxic chemotherapy or known radiosensitizing agents within 5 days before or after lattice therapy.
- •Patients with hematologic malignancies including lymphoma and leukemia as well as primary or metastatic central nervous system (CNS) malignancies.
- •Patients with a history of conditions which predispose them to increased radiation toxicity
- •Patients with known contraindications to radiation therapy
- •Patients with uncontrolled intercurrent illness
- •Pregnant women
研究组 & 干预措施
Lattice radiation therapy (LRT)
Lattice radiation therapy (LRT) : 5 fractions
干预措施: Lattice therapy (LRT) (Radiation)
结局指标
主要结局
Overall Response Rate
时间窗: 60 days post treatment
To evaluate the efficacy of lattice therapy in patients with bulky tumors, as measured by objective response rate (ORR) at 60 days post-treatment.
Adverse Events
时间窗: Up to 60 days post-treatment
To characterize the safety profile and adverse events (AEs) of lattice therapy.
次要结局
- Patient-reported Quality of Life(60 days post treatment)
- Overall Survival(12 months post treatment)
研究者
Andrew Frankart
Principal Investigator
University of Cincinnati